Heart valve replacement surgeries are very commonly performed all over the world, and presently, at least 90,000 heart valve replacements are performed each year in the United States alone, and more than 500,000 are performed all across the globe. Current surgical heart valve implantation is a highly skilled surgical procedure and invariably takes prolonged time duration. During this procedure the patient is on cardiopulmonary bypass and is subjected to the adverse effects of such prolonged bypass time.
Presently, during heart valve replacements, trauma to blood on the heart lung machine is known to lead to various bleeding complications and also end organ failure. Minimizing the cardio pulmonary bypass time is the main objective of seeking new advances in heart valve implantation procedures. The minimized bypass time should improve clinical outcomes greatly and decrease overall patient mortality.
Ever since the heart lung machine was invented in 1953, various cardiac surgical procedures have been performed, and Hufnagal implanted the first mechanical prosthesis in a descending thoracic aorta to inaugurate the concept of prosthetic valve implantation. The prior art technique of implanting a prosthetic valve (having a Dacron® sewing ring) on the valve annulus basically involved applying a multiplicity of Teflon-pledgeted sutures sequentially around the aortic (or mitral) annulus and passing a plurality of needles (two for each suture) through the Dacron® sewing ring of the prosthetic valve and tying the knots in place to secure the prosthetic valve to the patient's annulus for implantation.
Implantation of sutureless valves using staples only, has been attempted in the past, and, Magovern-Cromie sutureless valves were implanted in 1963. Both Mitral and Aortic prosthetic sutureless valves were clinically implanted with varying results and success. In such installations however, perivalvular leaks were reportedly a problem along with heart blocks.
There are examples of heart valve replacement tools and procedures with differing results and practical limitations. U.S. Pat. No. 5,984,959 to Robertson et al teaches an expandable heart valve installation assembly and an expandable ring installation assembly. U.S. Pat. No. 6,096,074 to Pedros teaches a stapling apparatus and method for heart valve replacement wherein a plurality of staples having sutures attached thereto, are discharged from a surgical stapler into the heart. U.S. Pat. No. 6,203,553 B1 to Robertson et al teaches a stapling apparatus having a first cylindrical portion, and a second concentric cylindrical portion with a camming arm configured to cam a staple assembly outwards in a radial direction. U.S. Pat. No. 6,676,671 B2 to Robertson et al teaches a stapling apparatus with a first cylindrical portion having a cam, a concentric second cylindrical portion and a third cylindrical portion concentric about the second cylindrical portion and having an anvil flange. The heart valve stapling arrangements known hitherto have disadvantages in terms of exposing the patient to prolonged durations on the heart-lung machine during the valve replacement.
There is therefore a need for a system and method for heart valve replacement obviating the disadvantages of prior art and reducing the cardio pulmonary bypass time for the patient.